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Abstract Background The standards of care in reflux disease management are proton pump inhibitor (PPI) therapy and conventional antireflux surgery, however, both options carry the caveats of medication irresponsiveness and troublesome postoperative sequelae, respectively. More specifically, PPIs respond inadequately in up to 40% of cases and Nissen fundoplication is associated with postoperative dysphagia in a significant proportion of patients. RefluxStop is an innovative technology that was adopted at our two respective institutions following promising safety and effectiveness data from its CE mark trial. We present the pooled safety and quality-of-life data of our 1-year experience with RefluxStop surgery. Methods Between September 2018 and August 2023, RefluxStop surgery was performed on 121 patients as part of routine clinical care at two hospitals, both of which are high-volume centers for antireflux surgery. The procedure involves crural repair with hiatal hernia reduction, reconstruction of the flap valve and angle of His, narrow esophagogastric (90-110°) plication, and device implantation in an external pouch on the gastric fundus (Figure 1). A retrospective chart analysis was conducted to document perioperative adverse events (AEs) and quality-of-life improvements via Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) score. Higher GERD-HRQL scores are indicative of more severe disease. Results Baseline patient characteristics included mean age 54.7 years, female sex (52.9%), body mass index 27.2±4.1 kg/m2, large hiatal hernia 3 cm (46.3%) of median (IQR) size 3 (2-5) cm, abnormal esophageal motility (60.3%), and Barrett’s esophagus (27.3%). At 1-year follow-up, patients experienced a median (IQR) reduction of 90.5% (81.4-100%) in total GERD-HRQL score. Intraoperative AEs included conversion to laparotomy for adhesiolysis with bleeding (n=1), bleeding short gastric arteries leading to return to the operating room the next day (n=1), and esophageal perforation repaired intraoperatively (n=1). Postoperative AEs are summarized in Table 1. Conclusion The results of this pooled retrospective chart analysis support the promising early data of the RefluxStop CE mark trial. Few and predictable AEs occurred during the study period while significant improvements in quality of life were observed, as evidenced by 90.5% (81.4-100%) reductions in GERD-HRQL score. Notably, this pooled cohort of patients was comprised of substantial proportions of difficult-to-treat patients (i.e., abnormal esophageal motility in 60.3%, large hiatal hernia 3 cm in 46.3%), providing evidence for wider implementation of RefluxStop surgery in real-world settings. Additional evaluation is required to further delineate the role of this promising innovative antireflux surgery.
Zehetner et al. (Sun,) studied this question.